FDA product code HZJ: Stain, Papanicolau
HZJ is the FDA product code for stain, papanicolau. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 15 510(k) submissions under HZJ, from 6 different applicants. The average 510(k) review took 30 days (median 22). FDA has posted 2 recalls for HZJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Stain, Papanicolau |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HZJ clearance
Top HZJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 4 | 1984-09-11 |
| Volu Sol Medical Industries | 3 | 1982-08-03 |
| Surgipath | 3 | 1982-02-04 |
| Bioscientific | 3 | 1978-10-10 |
| Accra Laboratories, Inc. | 1 | 1984-10-02 |
1 more applicants have HZJ clearances. See the full list in Caduvo.
Most recent HZJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843427 | Accra Laboratories, Inc. | GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 | 1984-10-02 | 28 |
| K842735 | E K Ind., Inc. | PAP STAIN EA-65 | 1984-09-11 | 60 |
| K842739 | E K Ind., Inc. | PAP STAIN, EA-36 | 1984-09-11 | 60 |
| K842736 | E K Ind., Inc. | PAP STAIN, OG-6 | 1984-08-17 | 35 |
| K842738 | E K Ind., Inc. | PAP STAIN EA-50 | 1984-08-17 | 35 |
Recalls for HZJ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-02-19.
Frequently asked questions
What is FDA product code HZJ?
HZJ is the FDA product code for stain, papanicolau. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HZJ?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HZJ?
Across 15 cleared submissions the average was 30 days from receipt to decision (median 22).
Which companies have the most HZJ clearances?
E K Ind., Inc. (4); Volu Sol Medical Industries (3); Surgipath (3); Bioscientific (3); Accra Laboratories, Inc. (1).
Have HZJ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-02-19.
Next steps
- Run an FDA pathway report with predicate devices for product code HZJ
- Run a recall and safety report across every HZJ manufacturer
- Watch product code HZJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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